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ChemoCentryx surges on phase 3 vasculitis study

Shares in the US biotech rose 227% after announcing trial results


ChemoCentryx’ complement C5a inhibitor avacopan has outperformed standard corticosteroid therapy in a phase 3 vasculitis trial, causing a spike in its share price and analyst speculation it may have a blockbuster drug on its hands.

Shares in the US biotech rose 277% after it announced the ADVOCATE trials results in anti-neutrophil cytoplasmic antibody-associated vasculitis (ANCA) vasculitis, a rare, life-threatening disease caused by overactivity in the complement immune system.

The positive results set up regulatory filings in both the US and Europe next year, according to ChemoCentryx, which has licensed ex-US rights to Switzerland’s Vifor Fresenius Medical Care Renal Pharma (VFMCRP), a joint venture between Vifor Pharma and Fresenius.

All told, 72% of the patients treated with the orally-active drug were in remission after 26 weeks, a result which matched the 70% rate achieved with the comparator steroid regimen.

Moreover, at the 52-week timepoint the remission rate was almost 66% in the avacopan group, a statistically significant improvement on the 55% rate seen with steroids with a p-value of 0.0066.

As expected, avacopan was also associated with less steroid-related toxicity – a key secondary outcome measure in the trial – while patients on the drug also improved kidney function and had better quality-of-life scores.

The result puts avacopan on course to become a new standard treatment for ANCA vasculitis, which is characterised by inflammation of blood vessels that can lead to organ damage, particularly affecting the kidney, and can be fatal if untreated.

At the moment ANCA vasculitis is treated with a combination of potent steroids like prednisolone with immunosuppressive drugs like cyclophosphamide or Roche’s Rituxan/MabThera (rituximab).

These therapies can cause significant side effects including weight gain, mood swings, muscle weakness and infections – caused by the steroids – as well as other toxicities from the other drugs, for example haemorrhagic cystitis can be seen with cyclophosphamide.

ChemoCentryx’ chief executive Thomas Schall said that the results “exceed our expectations” and have the potential to make current therapy obsolete, if avacopan is approved for marketing.

“We have for the first time demonstrated that a highly targeted therapy aimed at the very centre of the ANCA disease process is superior to the traditional approach of broad immune suppression therapy,” he added.

The comprehensive win also took analysts by surprise, particularly as a similar drug in development at German biotech InflaRx – IFX-1 – disappointed in a mid-stage trial in hidradenitis suppurativa (HS), another disease thought to be mediated by complement. IFX-1 is also in development for ANCA vasculitis.

The HS result allowed some scepticism to creep in about the prospects for the C5a inhibitor class which seems to have been all-but laid to rest with the ChemoCentryx trial.

A number of analysts are now predicting sales of $1bn or more for avacopan, with the potential to go even higher if it hits the mark in all the other indications ChemoCentryx is targeting. Those include C3 glomerulopathy, a group of kidney diseases, as well as moderate-to-severe HS.

Article by
Phil Taylor

27th November 2019

From: Research



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